Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Subjects With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)

• Status: Completed
• Trial end date: 2020-03-30
• Target enrollment: 0
• Participant gender: All

Summary

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in subjects with incident DD-CKD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akebia Therapeutics
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• ≥18 years of age

• Initiated chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease within 16 weeks prior to Screening

• Mean Screening hemoglobin between 8.0 and <11.0 g/dL (inclusive)

Exclusion Criteria:

• Subjects meeting the criteria of ESA resistance within 8 weeks prior to or during Screening defined as follows

1. epoetin: > 7700 units/dose three times per week or >23,000 units per week

2. darbepoetin alfa: >100 mcg/week

3. methoxy polyethylene glycol-epoetin beta: >100 mcg every other week or >200 mcg/month

• Anemia due to a cause other than CKD or subjects with active bleeding or recent blood loss

• Anticipated to recover adequate kidney function to no longer require dialysis

• Uncontrolled hypertension

• Severe heart failure at Screening (New York Heart Association Class IV)

• Acute coronary syndrome (hospitalization for unstable angina, myocardial infarction); surgical or percutaneous intervention for coronary, cerebrovascular, or peripheral artery disease (aortic or lower extremity); surgical or percutaneous valvular replacement or repair; sustained ventricular tachycardia; hospitalization for CHF; or stroke within 12 weeks prior to or during Screening.

• Hypersensitivity to vadadustat, darbepoetin alfa or any of their excipients